NCT04144647

Brief Summary

The co-ordination and control of body segments are integral in providing and maintaining postural stability. It is widely accepted that attentional demands for postural control are placed upon the individual, but these vary according to the nature of the task, the age of the individual and their postural stability. It is thought that divided attention (a technique whereby two tasks are performed at the same time whilst rapidly switching attention between the two tasks) is commonly used when multi-tasking. Divided attention may have important clinical implications to falls risk, in that older adults that experience falls have increased difficulty in switching attention between tasks such as walking and talking. Dual tasking paradigms which present postural and cognitive tasks are often used to test attentional demands for posture control and interference between the two tasks. At present it is not known what impact balance confidence, sleep, activity levels or cognitive ability impact on a person's ability to multi-task when performing complex walking tasks that reflect the complexity of mobilising in real-life situations.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 24, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

October 28, 2019

Last Update Submit

April 23, 2020

Conditions

Keywords

dual-taskingCANTABGaitCognitionSleepactivity

Outcome Measures

Primary Outcomes (1)

  • Functional Gait Assessment

    The primary outcome is the Functional Gait Assessment which is a 10-item test that assesses performance on complex gait tasks (i.e. walking with head turns, stepping over an obstacle or stopping and turning). Scores range from 0 to 30. The highest score is 30 and greater outcomes are indicative of better performance while lower scores are indicative of poorer performance. The Functional Gait Assessment has been validated in healthy people, older adults with a history of falls and balance impairments, and people with a vestibular disorder. The minimal detectable change for Functional Gait Assessment is reported to be 6 points in persons with balance and vestibular disorders. Scores ≤22/30 identify fall risk and are predictable of falls in community-living older persons within 6 months.

    5 minutes

Secondary Outcomes (14)

  • Functional Gait Dual-Task Test

    30 minutes

  • Mini-Balance Evaluation Systems Test

    5 minutes

  • Cambridge Neuropsychological Test Automated Battery

    45 minutes

  • Standard pure tone audiometry

    10 minutes

  • Speech in Babble Test

    10 minutes

  • +9 more secondary outcomes

Study Arms (1)

Healthy adults 18-80 years old

EXPERIMENTAL

Healthy adults 18-80 years old

Other: Single testing session

Interventions

All participants that meet the inclusion criteria, will have to attend the research laboratory at Centre for Human and Applied Physiological Sciences, Shepherd's House, Guy's Campus, King's College London, SE1 1UL to be assessed in a single testing session. The testing session will require them to complete some questionnaires regarding balance confidence, psychological state, sleep and physical function and to undertake some simple tests of cognitive function. They will also undertake a brief dynamic balance assessment and the dual-task gait test. The dual-task component involves two cognitive tasks (a numeracy and a literacy task) or auditory task. The gait test will be performed separately and then together with each of two cognitive tasks or auditory task. On the day, after the testing, each participant will, also, be provided a physical activity monitor (accelerometer-AX3) to wear on their wrist for 24 hours a day, seven days a week without taking it off.

Also known as: Observational
Healthy adults 18-80 years old

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • community-dwelling healthy adults
  • aged 18-80 years old
  • independently mobile.

You may not qualify if:

  • Individuals have a central nervous system disorder vestibular disorder and/or acute orthopaedic/musculoskeletal disorder affecting balance control and/or gait
  • individuals with lack of a good grasp of written and spoken English language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Human and Applied Physiological Sciences, King's College London

London, SE1 1UL, United Kingdom

RECRUITING

Related Publications (30)

  • Lacour M, Bernard-Demanze L, Dumitrescu M. Posture control, aging, and attention resources: models and posture-analysis methods. Neurophysiol Clin. 2008 Dec;38(6):411-21. doi: 10.1016/j.neucli.2008.09.005. Epub 2008 Oct 9.

  • Woollacott M, Shumway-Cook A. Attention and the control of posture and gait: a review of an emerging area of research. Gait Posture. 2002 Aug;16(1):1-14. doi: 10.1016/s0966-6362(01)00156-4.

  • Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720.

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  • Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.

  • Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.

  • Marchetti GF, Lin CC, Alghadir A, Whitney SL. Responsiveness and minimal detectable change of the dynamic gait index and functional gait index in persons with balance and vestibular disorders. J Neurol Phys Ther. 2014 Apr;38(2):119-24. doi: 10.1097/NPT.0000000000000015.

  • Wrisley DM, Kumar NA. Functional gait assessment: concurrent, discriminative, and predictive validity in community-dwelling older adults. Phys Ther. 2010 May;90(5):761-73. doi: 10.2522/ptj.20090069. Epub 2010 Apr 1.

  • Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.

  • Leddy AL, Crowner BE, Earhart GM. Utility of the Mini-BESTest, BESTest, and BESTest sections for balance assessments in individuals with Parkinson disease. J Neurol Phys Ther. 2011 Jun;35(2):90-7. doi: 10.1097/NPT.0b013e31821a620c.

  • King L, Horak F. On the mini-BESTest: scoring and the reporting of total scores. Phys Ther. 2013 Apr;93(4):571-5. doi: 10.2522/ptj.2013.93.4.571. No abstract available.

  • Cambridge-Cognition-Limited. CANTABeclipseâ„¢: Test Administration Guide Manual. 3rd ed. Cambridge 2015.

    RESULT
  • Egerhazi A, Berecz R, Bartok E, Degrell I. Automated Neuropsychological Test Battery (CANTAB) in mild cognitive impairment and in Alzheimer's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Apr 13;31(3):746-51. doi: 10.1016/j.pnpbp.2007.01.011. Epub 2007 Jan 16.

  • Fowler KS, Saling MM, Conway EL, Semple JM, Louis WJ. Paired associate performance in the early detection of DAT. J Int Neuropsychol Soc. 2002 Jan;8(1):58-71.

  • Bamiou DE, Iliadou VV, Zanchetta S, Spyridakou C. What Can We Learn about Auditory Processing from Adult Hearing Questionnaires? J Am Acad Audiol. 2015 Nov-Dec;26(10):824-37. doi: 10.3766/jaaa.15009.

  • British Society of Audiology. Standard pure tone audiometry. British Society of Audiology-BSA 2017.

    RESULT
  • British Society of Audiology. Standard pure tone audiometry. British Society of Audiology-BSA 2011.

    RESULT
  • Doherty A, Jackson D, Hammerla N, Plotz T, Olivier P, Granat MH, White T, van Hees VT, Trenell MI, Owen CG, Preece SJ, Gillions R, Sheard S, Peakman T, Brage S, Wareham NJ. Large Scale Population Assessment of Physical Activity Using Wrist Worn Accelerometers: The UK Biobank Study. PLoS One. 2017 Feb 1;12(2):e0169649. doi: 10.1371/journal.pone.0169649. eCollection 2017.

  • Lee IM, Shiroma EJ. Using accelerometers to measure physical activity in large-scale epidemiological studies: issues and challenges. Br J Sports Med. 2014 Feb;48(3):197-201. doi: 10.1136/bjsports-2013-093154. Epub 2013 Dec 2.

  • Clarke CL, Taylor J, Crighton LJ, Goodbrand JA, McMurdo MET, Witham MD. Validation of the AX3 triaxial accelerometer in older functionally impaired people. Aging Clin Exp Res. 2017 Jun;29(3):451-457. doi: 10.1007/s40520-016-0604-8. Epub 2016 Jul 19.

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  • Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  • Guerraz M, Yardley L, Bertholon P, Pollak L, Rudge P, Gresty MA, Bronstein AM. Visual vertigo: symptom assessment, spatial orientation and postural control. Brain. 2001 Aug;124(Pt 8):1646-56. doi: 10.1093/brain/124.8.1646.

  • Bisdorff A, Von Brevern M, Lempert T, Newman-Toker DE. Classification of vestibular symptoms: towards an international classification of vestibular disorders. J Vestib Res. 2009;19(1-2):1-13. doi: 10.3233/VES-2009-0343. No abstract available.

  • Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.

  • Whitney SL, Wrisley DM, Brown KE, Furman JM. Is perception of handicap related to functional performance in persons with vestibular dysfunction? Otol Neurotol. 2004 Mar;25(2):139-43. doi: 10.1097/00129492-200403000-00010.

  • Skerrett TN, Moss-Morris R. Fatigue and social impairment in multiple sclerosis: the role of patients' cognitive and behavioral responses to their symptoms. J Psychosom Res. 2006 Nov;61(5):587-93. doi: 10.1016/j.jpsychores.2006.04.018.

  • Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.

  • Lajoie Y, Gallagher SP. Predicting falls within the elderly community: comparison of postural sway, reaction time, the Berg balance scale and the Activities-specific Balance Confidence (ABC) scale for comparing fallers and non-fallers. Arch Gerontol Geriatr. 2004 Jan-Feb;38(1):11-26. doi: 10.1016/s0167-4943(03)00082-7.

MeSH Terms

Conditions

Motor Activity

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Viktoria Azoidou

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This is a simple case-controlled study of physiotherapy assessments. It doe snot include masking procedures.
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: 100 healthy participants aged between 18-80 years old are recruited for this study. All individuals that express interest in this study, will be provided with a Participant Information Sheet (PIS) either by email or hard copy by post. All prospective subjects will be screened for matching of inclusion criteria. After a potential participant contacts the PhD student, Ms Viktoria Azoidou, regarding his/her interest in participating in the study, the person will be asked to complete the screening questionnaire via telephone or email as per each individual's preference regarding eligibility criteria. If after screening, a potential participant meets the eligibility criteria, an appointment will be arranged to discuss any concerns or answer any questions participants may have regarding the PIS, then sign the written consent form and be assessed attend the research laboratory for the single testing session.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

February 25, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

April 24, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Participants' data will be processed in accordance with the General Data Protection Regulation 2016 (GDPR). All information collected will be kept strictly confidential and stored anonymously on password protected computers used only by research staff. Data will be stored securely in accordance with the Data Protection Act (1998) and the General Data Protection Regulations which came into effect on 25 May 2018. Participants' data will not be passed on to anyone outside of study research team. Stored, anonymised data may be used for future medical and health-related studies. Data will be retained for 10 years after it has been collected.

Locations